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510(k) K873740

ROTASCREEN EIA by Mercia Diagnostics , Ltd. — Product Code LIQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1987
Date Received
September 15, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorbent Assay, Rotavirus
Device Class
Class I
Regulation Number
866.3405
Review Panel
MI
Submission Type

Other clearances by Mercia Diagnostics , Ltd.

  • K915479 — CAPTIA CMV-TA (May 4, 1992)
  • K904524 — CAPTIA(R) SYPHILIS M, MODIFICATION (December 26, 1990)
  • K900654 — MODIFIED CAPTIA(R) SYPHILIS-M (March 8, 1990)
  • K896194 — CAPTIA(R) CMV-G (March 6, 1990)
  • K896295 — CAPTIA(R) CMV-M (March 6, 1990)
  • K900655 — MODIFIED CAPTIA(R) TOXO-M (March 6, 1990)
  • K885300 — CAPTIA(R) RUBELLA-M (August 15, 1989)
  • K883924 — CAPTIA(R) RUBELLA-G (August 15, 1989)
  • K892802 — SUPER DUO (June 13, 1989)
  • K881425 — CAPTIA(R) SYPHILIS-G (August 4, 1988)

Other clearances for product code LIQ

  • K990842 — SAS ROTA TEST (August 9, 1999)
  • K972895 — VIDAS ROTAVIRUS (RTV) ASSAY (October 3, 1997)
  • K971585 — IMMUNOCARD STAT! ROTAVIRUS (August 20, 1997)
  • K964424 — ROTAVIRUS EIA (August 8, 1997)
  • K965092 — VIDAS ROTAVIRUS ASSAY (May 5, 1997)
  • K951208 — ROTA-DAN RAPID ROTAVIRUS EIA KIT (February 14, 1996)
  • K942286 — DIARLEX ROTA-ADENO (December 14, 1994)
  • K933587 — IMMUNOCARD ROTAVIRUS (February 3, 1994)
  • K932384 — IDEIA(TM) ROTAVIRUS (December 27, 1993)
  • K915137 — KALLESTAD ROTAVIRUS MICROPLATE (March 4, 1992)